American drug-maker Pfizer and its German collaborator BioNTech have received an emergency-use authorisation (EUA) on their Covid-19 vaccine, making it the first to get off-the-blocks in the United States.
The EUA allows the vaccine to be distributed in the US, and it comes days after the United Kingdom gave a similar approval on the vaccine. The UK is presently vaccinating high-risk individuals, even as it cautioned those with a history of allergies to not take the vaccine, following two adverse events that were reported.
On the US green-light to the vaccine, FDA Commissioner Stephen M Hahn saidthe EUA followed “an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency-use authorisation.”
Pfizer has applied for an EUA in India as well, and in a recent industry interaction, Albert Bourla, Pfizer Chairman and Chief Executive Officer, told BusinessLine that they were working on versions of the vaccine that could be used in countries like India as well. The vaccine faces a major challenge in storage and distribution, as it requires temperatures of – (minus) 70 degrees Celsius.
Other countries such as Bahrain, Canada, Saudi Arabia and Mexico have approved the Pfizer-BioNTech vaccine.
Safety data
The USFDA said that the data available supported that “the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.” In making this determination, the FDA assured it had conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information, the regulator said.
The Pfizer-BioNTech vaccine contains messenger RNA (mRNA), which is genetic material. “The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2,” the regulator explained.
Side-effects
The Pfizer BioNTech vaccine involves two doses, three weeks apart. Among the commonly reported side effects that lasted several days were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever. More people experienced these side effects after the second dose, the FDA said, adding that it was important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more after the second dose.
The vaccine was 95 per cent effective in preventing Covid among the clinical trial participants. However, data was not available on how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person, the FDA said.